Customed Recalls Cysto TUR Packs Due to Potential Sterility Loss
Customed, Inc. is recalling Cysto TUR Pack Basic surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (injury due to contamination or loss of sterility) in a medical device where no specific injuries or illnesses have been reported yet, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling the Cysto TUR Pack Basic (Code 900-2899) due to a potential compromise in packaging integrity. The recall affects two specific lots (140111333 and 140412673), totaling 128 units. These surgical convenient packs are EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The company determined that the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients who use the affected products during surgical procedures.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Code 900-2899
- 2 lots 140111333 140412673
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 233 products in this recall →Related recalls
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